A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

753

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

November 30, 2007

Study Completion Date

November 30, 2007

Conditions
SchizophreniaPsychotic Disorders
Interventions
DRUG

Aripiprazole

10-30 mg oral once daily for 104 weeks

DRUG

Risperidone Long Acting Injectable (LAI)

25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.

DRUG

Quetiapine

Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.

Trial Locations (96)

Unknown

Hall in Tirol

Linz

Neunkirchen

Pleven

Sofia

Sofia Sofia

Osijek

Rijeka

Split

Zagreb

Brno

Lnáře

Opava

Pardubice

Plzen Czechia

Prague

Praha 2 N/A

Uherský Brod

Ústí nad Labem

Middelfart

Vordingborg

Pÿrnu N/A

Tallinn

Tartu

Bron

Brumath

Créteil

Dieppe

Hénin-Beaumont

Mont-Saint-Martin

Poitiers

Reims

Roubaix

Toulouse

Augsburg

Berlin

Bochum

Duisburg

Düsseldorf

Karlstadt am Main

Krefeld

München

Oranienburg

Stralsund

Heraklion -Crete

Thessalonikis

Budapest

Gyõr

Gyula

Kistarcsa

Szeged

Vác

Cork

Dublin

Kerry

Sligo

Jerusalem

Ramat Gan

Tel Aviv

Jelgava

Riga

Alytus

Kaunas

Klaipėda

Šiauliai

Vilnius

Choroszcz

Gdynia Na

Poznan

Warsaw

Coimbra

Porto

Bucharest

Craiova

Iași

Khobar

Košice

Zvolen

Begunje na Gorenjskem

Ljubljana

Ormož

Madrid

Oviedo (Asturias)

Seville

Valencia

Gothenburg

Trollhättan

Ankara Turkey

Bakirkoy/Istanbul N/A

Istanbul

Izmir

Barnet

Barnsley

Hull

Llantrissant

Swansea

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT00216476 - A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder | Biotech Hunter | Biotech Hunter